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THD Revolution

FDA UDIFDA 510(k)EUDAMED

Class II (US FDA UDI)

510(k) K141657

by Thd Spa

Identity

Trade Name
THD Revolution FDA UDI
Generic Name
Invasive vascular ultrasound system probe FDA UDI
Device Name
THD Slide is specifically designed to be immediately used with the THD Evolution/Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD Slide One box contains 10 individually packed disposable doppler probes, which can be immediately be used without preventive cleaning and sterilisation. The box also con-tains 10 absorbable sutures packs (6 sutures each pack) and 10 THD Spon-Anal haemostatic sponges FDA UDI
Model / Reference
THD Slide One USA FDA UDI
Description
THD Slide is specifically designed to be immediately used with the THD Evolution/Revolution doppler de-arterialiser. THD Slide is a specifically designed anoscope/proctoscope for improving the THD procedure while treating the higher grades of the haemorrhoidal disease. The specific shape of the anoscope/proctoscope, which includes a sliding part, allows to perform the ligation and the prolapse reduction with the same device and reduces the disease for the patient and speeds up the procedure. The peculiar shape of the anoscope/proctoscope, with the sliding probe holder, allows to perform ligation and prolapse reduction with a single tool. The THD Slide anoscope/proctoscope is made in a clear, medical grade, plastic which allows, with the use of the shaped fibre optic tip, a perfect lightning of the operative field. The particular THD anoscope/proctoscope is designed to maintain the right strain into the anal cavity during the treatment and it presents a lodge for the THD needle holder. The supplied doppler probe lodges into the anoscope/proctosocpe and is in contact with the anal mucosa for an accurate detection of the haemorrhoidal arteries. The THD Slide One box contains 10 individually packed disposable doppler probes, which can be immediately be used without preventive cleaning and sterilisation. The box also con-tains 10 absorbable sutures packs (6 sutures each pack) and 10 THD Spon-Anal haemostatic sponges FDA UDI

Identifiers

Catalog Number
800070 FDA UDI
Primary DI / UDI-DI
08033737710739 FDA UDI
510(k) Number
K090009 FDA UDI
FDA Product Code
JAF FDA UDI
GMDN Term
Invasive vascular ultrasound system probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Invasive vascular ultrasound system probeOptical anoscope, single-use

THD Revolution by Thd Spa — Class II — FDA_510K, MDR — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Optical anoscope, single-use.

Cleared under the same submission

K090009 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Unknown

MDR

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Manufacturer

Manufacturer
Thd Spa

Sources (3)

  • FDA UDI c0badd07-fc58-402a-9ce7-3dd35ce31bd8 60 fields · synced Jun 19, 2026
  • FDA 510(k) K141657 1 fields · synced Jun 5, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026